FDAFDA · Food and drugs·Recall number D-0250-2021
Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703, USA. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad-382 210, India NDC 16729-472-08 (Vial NDC 16729-472-30)
Published February 17, 2021 · Recall initiated: January 28, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- GLYCOPYRROLATE
- Manufacturer
- Accord Healthcare, Inc.
- Distributor
- Nationwide
- UPC
- 0316729474054
- Lot
- Lot: M2013645 Exp. Aug. 2022
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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